End Stage Renal DiseaseNCT03495271
Pilot Study of Taste Sensations in Patients With End-stage Renal Disease on Hemodialysis
An observational study of End Stage Renal Disease, run by Purdue University at 1 site in United States.
Trial summary
Individuals on dialysis due to kidney failure have very prescriptive diets. These diets help increase dialysis effectiveness and help patients control blood levels of electrolytes including potassium and phosphate, acid-base balance, blood pressure, and fluid between dialysis treatments. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2017to 19 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Subjects will be patients (N=36) undergoing hemodialysis and healthy controls (N=36), for comparison.
Who may be able to join
- Men and women
- Any race
- Age 18 years or older
- Maintenance hemodialysis patients
- No tongue, lip, or cheek piercings
- Over 18 years of age
Show all 9Show fewer
- Normal taste and smell function
- No known issues with salivation or dry mouth
- Willing to comply with study protocol (taste samples and provide saliva)
Who cannot join
- Patients with dysphagia who are not able consume the test solutions (clear, thin liquids).
- Control subjects:
Trial locations and contacts
1 site in 1 country.
About this study
Individuals on dialysis due to kidney failure have very prescriptive diets. These diets help increase dialysis effectiveness and help patients control blood levels of electrolytes including potassium and phosphate, acid-base balance, blood pressure, and fluid between dialysis treatments. However, patient compliance with these diets often can be very low, and one reason for this low compliance is disguesia (abnormal taste sensations) which can make the diets unpalatable. This experiment tests the hypothesis that disguesia, and subsequent lack of adherence to a dialysis friendly diet, is a result of either vascular taste (tasting your own blood through the basolateral side of taste cells) or altered chemical composition of saliva in between dialysis appointments. However, to study these hypotheses, data are needed on the types of substances that may contribute to the disguesia. Substances for which the concentration is influenced by kidney function (in healthy people) or dialysis (in patients) are the prime candidates for the disguesia under our hypotheses. Thus, this experiment tests whether taste or flavours experienced from sodium, calcium, potassium, creatinine, urea, phosphates, glutamate, and iron may be related to altered taste experienced by patients on dialysis.
Read the detailed description
- Background:
Individuals on dialysis due to kidney failure have very prescriptive diets. These diets help increase dialysis effectiveness and help patients control blood levels of electrolytes including potassium and phosphate, acid-base balance, blood pressure, and fluid between dialysis treatments. However, patient compliance with these diets is often very low, and one reason for this low compliance is disguesia (abnormal taste sensations) which can make the diets unpalatable. The investigators hypothesize this disguesia, and subsequent lack of adherence to a dialysis friendly diet, is a result of either vascular taste (tasting one's own blood through the basolateral side of taste cells) or altered chemical composition of saliva in between dialysis appointments. However, to study these hypotheses, data are needed on the types of substances that may contribute to the disguesia. Substances for which the concentration is influenced by kidney function (in healthy people) or dialysis (in patients) are the prime candidates for the disguesia under our hypotheses.
- Objectives:
The investigators will study how dialysis patients perceive sodium, calcium, potassium, creatinine, urea, phosphate, glutamate (umami taste), and iron solutions, and whether alterations in saliva may contribute to altered sensations from these compounds. These solutions will be used to:
- Determine whether dialysis patients recognize the flavour of specific stimuli as similar to the disguesias experienced between dialysis treatments.
- Determine if the intensity of the flavour from these solutions is more or less intense at the beginning of dialysis compared to the end.
- Determine if patients' ratings for the solutions differ from healthy, control individuals.
- Determine if saliva of patients contains different concentrations of analytes such as sodium, potassium, creatinine, urea, phosphates, iron, or glutamates from healthy controls.
- Determine if concentrations of these analytes in saliva decrease over the course of dialysis treatment.
- Conditions
- End Stage Renal Disease
- Keywords
- Hemodialysis, Taste, Blood, Saliva
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis Patients | Inclusion Criteria: * Patient's undergoing hemodialysis. * Male and female of any race * 18 years/ older. Those with dysphagia were excluded. In both participant groups, before each tasting protocol commences, sterile cotton dental rolls will be placed in the participant's mouth. This will be used to collect a saliva sample and determine salivary flow. Tasting Protocol: The hemodialysis patients will taste each solutions twice, both before and after their dialysis session. An sensory questionnaire and an open ended comment box will be given for participants to type in other words to describe the sensations. In dialysis patients only, blood will be drawn pre and post dialysis for serum ion concentrations. | |
| Healthy Controls | Inclusion Criteria * No tongue, lip, or cheek piercings * Over 18 years of age * Normal taste and smell function * No known issues with salivation or dry mouth * Willing to comply with study protocol (taste samples and provide saliva) The above protocol will be mimicked in the healthy control group. The only difference is that instead of a pre/post dialysis tastings, the control population will have a 2-4 hour gap in between tastings in order to follow the approximate time-frame of the dialysis patients. Finally they will not be required to provide blood samples. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste perception
Assess effect of dialysis on taste perceptions of solutions via sensory questionnaire. The scale used will be a generalized visual analog scale, which will ask participants about the intensity and hedonic quality of the sensations experienced. The scale ranges from 0 to 100 and are rated by the individuals when tasting the samples.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start6 Feb 2017
- Primary completion19 Apr 2017
- Study completion19 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Hill Gallant, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495271
- Sponsor's protocol ID
- 1611018504
- Status last verified
- Apr 2018
- First submitted
- 5 Nov 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lynch KE, Lynch R, Curhan GC, Brunelli SM. Altered taste perception and nutritional status among hemodialysis patients. J Ren Nutr. 2013 Jul;23(4):288-295.e1. doi: 10.1053/j.jrn.2012.08.009. Epub 2012 Oct 6.
PubMed 23046735Seethalakshmi C, Koteeswaran D, Chiranjeevi V. Correlation of Serum and Salivary Biochemical Parameters in end Stage Renal Disease Patients Undergoing Hemodialysis in Pre and Post-Dialysis State. J Clin Diagn Res. 2014 Dec;8(12):CC12-4. doi: 10.7860/JCDR/2014/10404.5306. Epub 2014 Dec 5.
PubMed 25653941
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Taste Sensations in Patients With End-stage Renal Disease on Hemodialysis
- ClinicalTrials.gov ID
- NCT03495271
- Acronym / sponsor ID
- 1611018504
- Conditions
- End Stage Renal Disease
- Keywords
- Hemodialysis, Taste, Blood, Saliva
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 19 Apr 2017 (actual)
- Study completion
- 19 Apr 2017 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals on dialysis due to kidney failure have very prescriptive diets. These diets help increase dialysis effectiveness and help patients control blood levels of electrolytes including potassium and phosphate, acid-base balance, blood pressure, and fluid between dialysis treatments. However, patient compliance with these diets often can be very low, and one reason for this low compliance is disguesia (abnormal taste sensations) which can make the diets unpalatable. This experiment tests the hypothesis that disguesia, and subsequent lack of adherence to a dialysis friendly diet, is a result of either vascular taste (tasting your own blood through the basolateral side of taste cells) or altered chemical composition of saliva in between dialysis appointments. However, to study these hypotheses, data are needed on the types of substances that may contribute to the disguesia. Substances for which the concentration is influenced by kidney function (in healthy people) or dialysis (in patients) are the prime candidates for the disguesia under our hypotheses. Thus, this experiment tests whether taste or flavours experienced from sodium, calcium, potassium, creatinine, urea, phosphates, glutamate, and iron may be related to altered taste experienced by patients on dialysis.
Detailed description
- Background:
Individuals on dialysis due to kidney failure have very prescriptive diets. These diets help increase dialysis effectiveness and help patients control blood levels of electrolytes including potassium and phosphate, acid-base balance, blood pressure, and fluid between dialysis treatments. However, patient compliance with these diets is often very low, and one reason for this low compliance is disguesia (abnormal taste sensations) which can make the diets unpalatable. The investigators hypothesize this disguesia, and subsequent lack of adherence to a dialysis friendly diet, is a result of either vascular taste (tasting one's own blood through the basolateral side of taste cells) or altered chemical composition of saliva in between dialysis appointments. However, to study these hypotheses, data are needed on the types of substances that may contribute to the disguesia. Substances for which the concentration is influenced by kidney function (in healthy people) or dialysis (in patients) are the prime candidates for the disguesia under our hypotheses.
- Objectives:
The investigators will study how dialysis patients perceive sodium, calcium, potassium, creatinine, urea, phosphate, glutamate (umami taste), and iron solutions, and whether alterations in saliva may contribute to altered sensations from these compounds. These solutions will be used to:
- Determine whether dialysis patients recognize the flavour of specific stimuli as similar to the disguesias experienced between dialysis treatments.
- Determine if the intensity of the flavour from these solutions is more or less intense at the beginning of dialysis compared to the end.
- Determine if patients' ratings for the solutions differ from healthy, control individuals.
- Determine if saliva of patients contains different concentrations of analytes such as sodium, potassium, creatinine, urea, phosphates, iron, or glutamates from healthy controls.
- Determine if concentrations of these analytes in saliva decrease over the course of dialysis treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis Patients | – | –Inclusion Criteria: * Patient's undergoing hemodialysis. * Male and female of any race * 18 years/ older. Those with dysphagia were excluded. In both participant groups, before each tasting protocol commences, sterile cotton dental rolls will be placed in the participant's mouth. This will be used to collect a saliva sample and determine salivary flow. Tasting Protocol: The hemodialysis patients will taste each solutions twice, both before and after their dialysis session. An sensory questionnaire and an open ended comment box will be given for participants to type in other words to describe the sensations. In dialysis patients only, blood will be drawn pre and post dialysis for serum ion concentrations. |
| Healthy Controls | – | –Inclusion Criteria * No tongue, lip, or cheek piercings * Over 18 years of age * Normal taste and smell function * No known issues with salivation or dry mouth * Willing to comply with study protocol (taste samples and provide saliva) The above protocol will be mimicked in the healthy control group. The only difference is that instead of a pre/post dialysis tastings, the control population will have a 2-4 hour gap in between tastings in order to follow the approximate time-frame of the dialysis patients. Finally they will not be required to provide blood samples. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be patients (N=36) undergoing hemodialysis and healthy controls (N=36), for comparison.
Key inclusion criteria (9 listed)
- Men and women
- Any race
- Age 18 years or older
- Maintenance hemodialysis patients
- No tongue, lip, or cheek piercings
Key exclusion criteria (2 listed)
- Patients with dysphagia who are not able consume the test solutions (clear, thin liquids).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Taste perception
Time frame: 1 day
Assess effect of dialysis on taste perceptions of solutions via sensory questionnaire. The scale used will be a generalized visual analog scale, which will ask participants about the intensity and hedonic quality of the sensations experienced. The scale ranges from 0 to 100 and are rated by the individuals when tasting the samples.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Background: PubMed 23046735Lynch KE, Lynch R, Curhan GC, Brunelli SM. Altered taste perception and nutritional status among hemodialysis patients. J Ren Nutr. 2013 Jul;23(4):288-295.e1. doi: 10.1053/j.jrn.2012.08.009. Epub 2012 Oct 6.
- Background: PubMed 25653941Seethalakshmi C, Koteeswaran D, Chiranjeevi V. Correlation of Serum and Salivary Biochemical Parameters in end Stage Renal Disease Patients Undergoing Hemodialysis in Pre and Post-Dialysis State. J Clin Diagn Res. 2014 Dec;8(12):CC12-4. doi: 10.7860/JCDR/2014/10404.5306. Epub 2014 Dec 5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste perception (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03495271, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.